Maternal Well-being in the Perinatal Period

ConditionsPerinatal Depression Anxiety Loneliness Mother-Child Relations

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

AgeNot listed

SponsorIRCCS San Raffaele

About this trial

The goal of this observation study is to investigate the mental health status of women experiencing their first pregnancy, with particular attention to anxiety and depression symptoms, feelings of loneliness, and the quality of defense mechanisms employed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Adequate understanding of the Italian language

Willingness to participate in the study, expressed through the signing of the information sheet, consent declaration, and privacy statement

Women experiencing their first pregnancy

Disqualifiers

Age under 18 years old

Women who are not able to understand the Italian language

Absence of the willingness to participate in the study, expressed through the signing of the information sheet, consent declaration, and privacy statement

Women who are not experiencing their first pregnancy

Trial population

We plan to recruit a sample of at least 134 patients. This sample size allows us to meet the recommendations obtained from conducting the power analysis. The sample size calculation was performed using G\*Power software (version 3.1.9.6, Faul et al., 2007).

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Questionnaires and focus groups
Other intervention
Participation in the research involves completing a test battery composed of self-administered questionnaires, all validated in the Italian language. Additionally, qualitative data will be collected through semi-structured interviews (conducted in person or online, based on individual preferences) and focus groups, both lasting between 90 and 120 minutes.

Treatment groups

134 Participants

are divided into 1 treatment group

Group A: Women during pregnancy and postpartum1 intervention

Trial outcomes